Evidence map›Paper›PMID 22006563›Full record

Trial reportHepatology (Baltimore, Md.)2012

Biochemical and immunologic effects of rituximab in patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid.

Masanobu Tsuda, Yuki Moritoki, Zhe-Xiong Lian, Weici Zhang, Katsunori Yoshida, Kanji Wakabayashi, Guo-Xiang Yang, Toshio Nakatani, John Vierling, Keith Lindor and 2 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed
5.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 148 citations in OpenAlex.

  1. Trial
  2. Rituximab for the treatment of patients with autoimmune hepatitis who are refractory or intolerant to standard therapy.Canadian journal of gastroenterology = Journal canadien de gastroenterologie · 2013
    Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. A Closer Look into Autoimmune Liver Diseases.International journal of molecular sciences · 2025
    Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. [The immune-modulation therapy of autoimmune liver diseases].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2021
    Article
  20. Review

6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 3 countries.

Masanobu TsudaDivisions of Rheumatology, Allergy, and Clinical Immunology, University of California, Davis, CA 95817, USA.
Yuki Moritoki
Zhe-Xiong Lian
Weici Zhang
Katsunori Yoshida
Kanji Wakabayashi
Guo-Xiang Yang
Toshio Nakatani
John Vierling
Keith Lindor
M Eric Gershwin
Christopher L Bowlus
University of California, Davis · USBaylor College of Medicine · USKansai Medical University · JPMayo Clinic · USUniversity of Science and Technology of China · CN

Funding

dnTGF Beta RII Mice and PBCR01DK090019 · NIDDK · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GERSHWIN, MERRILL E, RIDGWAY, WILLIAM M · 2010 to 2017
$3.8M
MECHANISMS AND PATHOGENESIS OF PRIMARY BILIARY CIRRHOSISR01DK039588 · NIDDK · UNIVERSITY OF CALIFORNIA DAVIS · PI GERSHWIN, MERRILL E · 1988 to 2015
$2.0M
NIDDK NIH HHS R01 DK039588NIDDK NIH HHS R01 DK090019
6 · The paper itself

Abstract

unlabelledThe aim of this study was to determine the safety and potential efficacy of B-cell depletion with the anti-CD20 monoclonal antibody rituximab in patients with primary biliary cirrhosis (PBC) and an incomplete response to ursodeoxycholic acid (UDCA). This open-label study enrolled six patients with PBC and incomplete responses to UDCA to be treated with 2 doses of 1000 mg rituximab separated by 2 weeks and followed for 52 weeks. The primary endpoints were safety and changes in B-cell function. Two patients received only 1 dose of rituximab, one due to activation of latent varicella and the other due to a viral upper respiratory infection. Serum levels of total IgG, IgM, and IgA as well as anti-mitochondrial autoantibodies (AMAs) IgA and IgM decreased significantly from baseline by 16 weeks and returned to baseline levels by 36 weeks. Stimulation of B cells with CpG produced significantly less IgM at 52 weeks after treatment compared with B cells at baseline. In addition, transient decreases in memory B-cell and T-cell frequencies and an increase in CD25(high) CD4(+) T cells were observed after treatment. These changes were associated with significant increases in mRNA levels of FoxP3 and transforming growth factor-β (TGF-β) and a decrease in tumor necrosis factor-α (TNF-α) in CD4(+) T cells. Notably, serum alkaline phosphatase levels were significantly reduced up to 36 weeks following rituximab treatment.

conclusionThese data suggest that depletion of B cells influences the induction, maintenance, and activation of both B and T cells and provides a potential mechanism for treatment of patients with PBC with an incomplete response to UDCA.

Indexed as

AdultAlkaline PhosphataseAntibodies, Monoclonal, Murine-DerivedAutoantibodiesB-LymphocytesCD4 Lymphocyte CountCholagogues and CholereticsFemaleHumansImmunologic FactorsImmunophenotypingLiverLiver Cirrhosis, BiliaryMiddle AgedRituximabRNA, MessengerAlkaline PhosphataseAntibodies, Monoclonal, Murine-DerivedAutoantibodiesCholagogues and CholereticsImmunologic FactorsRituximabRNA, MessengerUrsodeoxycholic Acid

Identifiers

PMID22006563
PMCPMC12168494
OpenAlexW1991543228

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.